(395 days)
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
- The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a regulated method for delivery of a specific volume of saline at a specific rate. The Marz Medical Blossom Syringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware, LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
- Supplied with the controller in a kit are the following components: Single use, sterile 10cc luer lock piston syringe, transfer set with proximal connection to the controller, and saline reservoir including distal connections to the inflation port of the expander, or via an infusion needle. All connections are luer lock compatible. The fluid path is clear that allows for visual inspection of the content.
The Marz Blossom Syringe Assist Device is a battery-operated device designed to assist clinicians in delivering sterile saline to fill temporary, removable tissue expanders. It includes a controller with an integrated syringe cradle for a 10cc syringe, firmware, LED displays, an external pressure sensor, and is powered by AA batteries. The device also comes with single-use, sterile 10cc luer lock piston syringes, a transfer set, and a saline reservoir.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Description | Reported Device Performance |
|---|---|
| Software/Firmware Verification: Verify software responds as designed under normal operating conditions (MRZ-TR-881). | All units passed the software verification testing under normal use and conditions. |
| Performance Verification: Verify the device can deliver saline to the tissue expander within specified parameters (MRZ-TR-882). | All devices passed testing in their typical operating modes and specifications for saline delivery. |
| Packaging Integrity (ISTA 2A): Verify packaging withstands shipping without damage or loss of function (MRZ-TR-880). Includes preconditioning, compression, shock/drop, vibration, and functional testing. | The device was not damaged and remained functional after standard transit testing (preconditioning, compression, shock/drop, vibration). The unit passed. |
| Shelf Life (6 Months): Verify tubing set adaptor accessory can be stored for 6 months without loss of sterility (MRZ-TR-886). Includes tensile test of pouch and dye penetration of the pouch. | All units passed all testing after accelerated aging at elevated temperatures to simulate a 6-month shelf life. |
| Thumb Force Equivalence: Compare actual thumb pressure to depress a 10ml syringe vs. force generated by the automated system (MRZ-TR-883). | Pass, force applied during injection is substantially equivalent to the manual approach (thumb pressure). |
| Comparative Product Analysis & System Forces/Pressures (Notebook Testing): Quantify pressures generated by the 10cc Luer Lock syringe system, forces required to recycle, max force and pressure generated by Marz device, and compare with 10cc and 60cc manual syringes. | The Blossom Syringe Assist device requires less force & pressure to dispense fluid than the 60cc syringe and its predicate, the McGhan Tissue fill kit. |
| Software Fault Conditions: Verify software fault conditions are verifiable during testing (MRZ-TR-955). | All fault conditions were verified, and the device responded as designed. The unit passed the verification testing. |
| EMC FCC Part 15 Subpart B: Electromagnetic Compatibility testing. | Pass |
| IEC 60601 Part 1 (1990, Amd A1:1993, A11:1993, A12; 1993; A2: 1995 and A13: 1996): Medical electrical equipment - General requirements for basic safety and essential performance. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not explicitly state the specific number of devices or components used as a "sample size" for each individual test. It consistently uses terms like "all units," "The devices," "The unit," and "units" when referring to the items tested. This suggests that the testing was conducted on a sufficient number of samples to demonstrate compliance with the criteria, likely following internal quality control procedures.
Data Provenance: The studies were conducted internally by Marz Medical, Inc. based on the report titles (e.g., MRZ-TR-881). The text does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's a pre-market notification, the data would typically be derived from prospective testing conducted during the device's development and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this device and its testing. The Marz Blossom Syringe Assist Device is a mechanical/electronic medical device. Its performance criteria are based on engineering specifications, physical measurements (e.g., fluid delivery, force, pressure), software functionality, and compliance with recognized standards (e.g., ISTA, EMC, IEC). It does not involve interpretation of medical images or patient data that would require "experts" to establish a "ground truth" in the way a diagnostic AI device would.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons mentioned in point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., medical imaging) where discrepancies between expert readers need to be resolved to establish ground truth. The testing for the Marz Blossom Syringe Assist Device involves objective, measurable physical and functional parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images) where the aim is to assess the impact of a device (like AI) on human performance. The Marz Blossom Syringe Assist Device is an assistive, mechanical device with objective performance metrics, not a diagnostic one requiring human interpretation of medical cases.
There was a "Thumb Force Test Report" (MRZ-TR-883) and "Comparative Product Analysis and System Forces and Pressures" which compared the device's force/pressure profile to manual approaches and predicate devices. However, these are engineering comparisons of physical characteristics, not an MRMC study assessing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is an "assist device" for a clinician. While its component tests (e.g., software verification, performance verification, fault conditions, EMC, IEC standards) evaluate the device's inherent functionality without direct human interaction during the test execution, the device's intended use is always "to assist the clinician." Therefore, the performance tests primarily focus on the device's standalone mechanical and electronic capabilities to fulfill its assistive role. There isn't a stated performance metric that evaluates the algorithm's performance in isolation from the physical device.
7. The Type of Ground Truth Used:
For this device, the "ground truth" is defined by:
- Engineering Specifications: Specific parameters for fluid delivery volume, rate, force, pressure, and software functionality that the device was designed to meet.
- Regulatory Standards: Compliance with recognized industry standards (e.g., IEC 60601, FCC Part 15, ISTA 2A) that define acceptable levels of safety and performance.
- Predicate Device Comparison: Establishing substantial equivalence by demonstrating similar or improved performance characteristics (e.g., force/pressure) compared to a legally marketed predicate device.
It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic medical device would be.
8. The Sample Size for the Training Set:
This information is not applicable to this device. As a mechanical/electronic assistive device, it does not employ machine learning or AI algorithms that require a "training set" of data in the conventional sense. The firmware and software are likely developed and validated through traditional software engineering methods, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8; no training set in the machine learning context is mentioned or implied for this device. The "ground truth" for its development would be its design requirements, functional specifications, and compliance with engineering principles and standards.
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IV. 510(k) Summary
Marz Blossom Syringe Assist Device
Submitter/Sponsor's Name, Address, Telephone Number, Contact Person and Date Prepared
Marz Medical, Inc. 2500 Hospital Drive, Bldg 9 2500 Hospital Drive, Blug 9
Mountain View, CA 94040---------------------------------------------------------------------------------------------------------------------------・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Contact Person: C/O Mary Pascual Gallup VP of Regulatory Affairs
Phone: 510-441-4017 (Direct Line) Fax: 510-487-1587
Date Prepared: 06/02/2013
Marz Blossom Syringe Assist device Name of Device:
Common or Usual Name: Tissue Expander Accessory (Syringe Assist, Accessory)
Classification Name
| Classification: | |
|---|---|
| Class: | |
| Classification Name: |
Jnclassified Jnclassified Tissue Expander Accessory
Predicate Device
The Marz Blossom Syringe Accessory System is substantially equivalent to its predicate McGhan Tissue expander Fill Kit (K853014) commercially available via the FDA 510(k) Pre-Market Notification with regards to intended use, design, materials and technology. The Marz Blossom Syringe Assist device does not raise new questions associated with safety and efficacy relative to such commercially available medical devices.
Indications for Use
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the
JUL 1 0 2014
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best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
Device Description
-
- The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a regulated method for delivery of a specific volume of saline at a -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------svringe. The Marz Medical Blossom Svringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware, LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
-
- Supplied with the controller in a kit are the following components: Single use, sterile 10cc luer lock piston syringe, transfer set with proximal connection to the controller, and saline reservoir including distal connections to the inflation port of the expander, or via an infusion needle. All connections are luer lock compatible. The fluid path is clear that allows for visual inspection of the content.
Technological Characteristics
The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a requlated method for delivery of a specific volume of saline at a specific rate. The Marz controller is compatible with 10cc plastic luer lock piston barrel syringe. The Marz Medical Blossom Syringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware. LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
The Marz Blossom Syringe Assist device controller has been evaluated for and has passed criteria for safety and performance testing. The Marz Blossom Syringe Assist device has also passed design verification and validation testing criteria in accordance with internal company controls and design control procedures to support the safety and intended use of the product.
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Performance Testing Conducted
The following tests were completed and reported results are summarized.
| Reference No./Description | Report Title | Overall Results |
|---|---|---|
| MRZ-TR-881 - Verifysoftware will respond asdesigned under normaloperating conditions. | Fluid Delivery System(FDS) Firmware/SoftwareVerification Test Report | The units were subjected tosoftware verification testingunder normal use andnormal conditions, all unitspassed the testing. |
| MRZ-TR-882 -- Verify thedevice can deliver saline tothe tissue expander withinthe parameters of thespecification. | Performance VerificationTest Report | The devices were subjectedto delivery of saline in theirtypical operating modesand specifications. Allunits passed testing. |
| MRZ-TR-880 - Verifypackaging can withstandshipping conditions withoutdamage or loss of functionto the device. This testingincluded:• Preconditioning.• Compression• Shock/Drop• Vibration Testing• Functional | ISTA 2A Packaging Test,Blossom System | The device was subjectedto std transit testing whichincluded:• Preconditioning.• Compression• Shock/Drop• Vibration Testing.The device were notdamaged and remainedfunctional after testing. Theunit passed. |
| MRZ-TR-886 - Verifytubing set adaptoraccessory can be stored for6 months without loss ofsterility.This testing included:• Tensile Test ofpouch.• Dye Penetration ofthe pouch. | 6 Month Shelf Life | The devices were subjectedto accelerated aging atelevated temperatures tosimulate 6 month shelf life.All units passed all testing. |
| Reference No./Description | Report Title | Overall Results |
| Tensile Test of joints found in the accessory assemblies. MRZ-TR-883 -- Thepurpose of this test was tocompare actual thumbpressure to depress a 10mlsyringe vs. the force | Thumb Force Test Report | Pass, force applied duringinjection is substantiallyequivalent to manualapproach (thumb pressure) |
| generated by theautomated system todepress a 10ml syringe. | ||
| Notebook TestingThe purpose of this testwas to quantify thepressures the 10cc LuerLock syringe with automaticspring return dispensingsystem could generate bydepressing the plunger andthe forces required torecycle the dispensingsystem.Additional tests wereconducted to determinemax force and pressuregenerated by the Marzdevice.Lastly, Forces required todepress the plunger andmax. pressure for 10cc and60cc single piston syringewithout automatic return vs.the Marz device. | Comparative ProductAnalysis and SystemForces and Pressures | Summary: The BlossomSyringe Assist devicerequires less force &pressure to dispense fluidthan the 60cc syringe, andits predicate, McGhanTissue fill kit. |
| MRZ-TR-955 -- Verify thatthe software fault | Marz Medical, Inc. FluidDelivery System Fault | All fault conditions wereverified, and the device |
| Reference No./Description | Report Title | Overall Results |
| conditions were verifiableduring testing. | conditions test Report. | responded as designed.The unit passed theverification testing. |
| EMC FCC Part 15 Subpart B | Pass | |
| IEC 60601 Part 1: 1990, Amd A1:1993, A11:1993, A12; 1993; A2: 1995 and A13: 1996 | Pass |
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Marz Medical, Inc. Blossom Delivery Assist Device K131692 510K Notification
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Substantial Equivalence
The Marz Blossom Syringe Assist device has the same intended uses and similar indications. technological characteristics, and principles of operation as its predicate device The McGhan Tissue Fill Kit (K853014). Both systems have two, one-way valves that prevent backflow into the fluid source, which is the saline bag. After a specified volume is delivered, both devices have an automatic refill feature. The technological differences between the Marz Syringe Assist/Accessory System and its predicate device raises no new issues of safety or effectiveness.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2014
Marz Medical Incorporated Ms. Mary Pascual Gallup Vice President of Regulatory Affairs 2500 Hospital Drive, Building 9 Mountain View, California 94040
Re: K131692
Trade/Device Name: Marz Blossom Saline Delivery Assist device Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LCJ Dated: June 6, 2014 Received: June 9, 2014
Dear Ms. Gallup:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Mary Pascual Gallup
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K131692
Device Name Blossom Syringe Assist Device
Indications for Use (Describe)
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indican in assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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